TANDEMHEART PUMP


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K110493
Device Name TANDEMHEART PUMP
Applicant
CARDIACASSIST INC.
240 alpha drive
pittsburgh, 
PA 
15238

Applicant Contact robert bollinger
Correspondent
CARDIACASSIST INC.
240 alpha drive
pittsburgh, 
PA 
15238

Correspodent Contact robert bollinger
Regulation Number 870.4360
Classification Product Code
KFM  
Date Received 02/22/2011
Decision Date 09/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No